Bonviva

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

ibandronic acid (ibandronic acid monosodium monohydrate)

Dostupné s:

F. Hoffmann-La Roche Ltd.

INN (Mezinárodní Name):

ibandronic acid (ibandronic acid monosodium monohydrate)

Dávkování:

150mg

Léková forma:

tablets film-coated

Druh předpisu:

Prescription

Informace pro uživatele

®
150 MG
FILM-COATED TABLETS
Ibandronic acid
Umschlag-Aussenseite
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PLANNING WHEN TO TAKE BONVIVA
The dose of Bonviva is one tablet once a month.
Choose one day of the month that will be easy
to remember:
–
either the same date (such as the 1st of each month)
–
or the same day (such as the first Sunday of each month).
Use the peel-off stickers below to mark the dates on your calendar.
Once you’ve taken your tablet, put a tick in the box on the sticker.
Bild 1 Bonviva
Umschlag-Innenseite
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PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR
Monthly tablet
Monthly tablet
Monthly tablet
It’s important to keep taking Bonviva every month. Remember to
contact your
doctor when you need a new prescription.
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IN THIS
LEAFLET:
PLANNING WHEN TO TAKE BONVIVA
PAGE
WITH PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR
2
1. DESCRIPTION
7
2. CLINICAL PARTICULARS
8
3. PHARMACOLOGICAL PROPERTIES AND EFFECTS
38
4. PHARMACEUTICAL PARTICULARS
58
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®
150 MG
FILM-COATED TABLETS
Ibandronic acid
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7
BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05)
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Bonviva is a nitrogen-containing bisphosphonate.
1.2
TYPE OF DOSAGE FORM
Film-coated tablets.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: ibandronic acid, monosodium salt, monohydrate.
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One 150 mg film-coated tablet contains 168.75 mg of ibandronic acid,
monosodium salt, monohydrate equivalent to 150 mg of ibandronic acid.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS _
Bonviva 150 mg is indicated for the treatment of postmenopausal
osteoporosis,
to reduce the risk of fractures.
Osteoporosis may be confirmed by the finding of l

Charakteristika produktu

December 2015
Summary of Product Characteristics
Ro 200-5450
Bonviva film-coated tablets
December 2015
1
BONVIVA
®
Ibandronic acid
BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05)
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Bonviva is a nitrogen-containing bisphosphonate.
1.2
TYPE OF DOSAGE FORM
Film-coated tablets.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: ibandronic acid, monosodium salt, monohydrate.
One 150 mg film-coated tablet contains 168.75 mg of ibandronic acid,
monosodium salt,
monohydrate equivalent to 150 mg of ibandronic acid.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS_
Bonviva 150 mg is indicated for the treatment of postmenopausal
osteoporosis, to reduce
the risk of fractures.
Osteoporosis may be confirmed by the finding of low bone mass (T-score
<-2.0 SD) and
the presence or history of osteoporotic fracture, or a low bone mass
(T-score < -2.5 SD) in
the absence of documented pre-existing osteoporotic fracture.
2.2
DOSAGE AND ADMINISTRATION
The recommended dose of Bonviva for treatment is one 150 mg
film-coated tablet once a
month. The tablet should preferably be taken on the same date each
month.
Bonviva should be taken 60 minutes before the first food or drink
(other than water) of
the day (see section 2.4.3 Interactions with other Medicinal Products
and other Forms of
Interaction, Drug-Food Interactions) or any other oral medication or
supplementation
(including calcium):
–
Tablets should be swallowed whole with a full glass of plain water
(180 to 240 ml)
while the patient is sitting or standing in an upright position.
Patients should not lie
down for 60 minutes after taking Bonviva.
December 2015
Summary of Product Characteristics
Ro 200-5450
Bonviva film-coated tablets
December 2015
2
–
Plain water is the only drink that should be taken with Bonviva.
Please note that some
mineral waters may have a higher concentration of calcium and
therefore should n